The on-demand PCR test has received FDA clearance with a CLIA waiver
Cepheid’s Xpert® Xpress MVP test has received FDA clearance with a CLIA waiver. Launched over a year ago, the multiplex vaginal panel (MVP) can now be performed in near-patient settings for results within 60 minutes from a single specimen for bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and trichomoniasis (TV).
Vaginitis and vaginosis are responsible for over 10 million visits per year to physician offices by women in the U.S., making it the most common gynecologic diagnosis in primary care.1
The on-demand PCR test runs on Cepheid’s GeneXpert Xpress instruments and is now approved for people 14 and older. Cepheid launched its Xpert® Xpress MVP test in the moderately complex category in November 2022 and received CLIA waiver in January 2024.
“With the addition of the CLIA waiver for MVP in our growing women’s health portfolio, physicians can quickly and accurately identify their patient’s infection and prescribe the correct treatment regimen, with the goal of avoiding multiple office visits associated with therapeutic failure,” said David Persing, M.D., Ph.D, EVP and Chief Medical and Scientific Officer for Sunnyvale,California.-based Cepheid, a molecular diagnostics company.
Co-infections of BV, VVC and TV, which all present with similar symptoms, are common. This complicates diagnosis and the guidance of appropriate treatment.2,3
“Misdiagnosis of the specific underlying causes of vaginitis and vaginosis often lead to inappropriate and ineffective treatments and, in some cases, an increased risk of developing serious complications and antibiotic resistant organisms,” Dr. Persing said.
The Xpert® Xpress MVP test delivers single-test confidence aiding clinicians in diagnosing three distinct conditions from one sample. This test introduces an algorithm for organisms associated with BV, combined with the detection of Candida species associated with VVC and TV.
The easy-to-use multiplex, real-time PCR panel test takes less than one minute hands-on-time with objective PCR results within 60 minutes. The test is designed to enable appropriate treatment the first time and the test is approved for use in CLIA-waived practices enabling molecular results at the point of care, significantly narrowing the test-to-treatment gap and better supporting patient outcomes.
Cepheid’s GeneXpert systems and Xpert tests automate highly complex and time-consuming manual procedures for institutions of any size to perform best-in-class PCR testing.
US-IVD. In Vitro Diagnostic Medical Device.
1 Brown H, et al. Improving the Diagnosis of Vulvovaginitis: Perspectives to Align Practice, Guidelines, and Awareness. Population Health Management 2020 23:S1, S-3-S-12
2 Gaydos CA, et al. Clinical Validation of a Test for the Diagnosis of Vaginitis. Obstetrics & Gynecology: July 2017 – Volume 130 – Issue 1 – p 181-189 doi: 10.1097/ AOG.0000000000002090
3 Schwebke J, et al. Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study. J Clin Microbiol 58:e01643-19.